Suture passing k-wire

ABSTRACT

A method for bunion repair using a suture passing K-wire configured to easily pass through bone tunnels with suture trailing. The suture passing K-wire includes a tapered guide pin with a multi-diameter shaft (i.e., comprising at least two regions or sections that have different diameters) and a loop which is securely attached to an end of the guide pin (i.e., to the smaller diameter section of the guide pin). The reconstruction system may be formed of a pair of buttons connected by a flexible strand. The procedure offers indirect placement of buttons and a minimally invasive approach.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/848,293, filed Mar. 21, 2013, now U.S. Pat. No. 9,204,874, which is acontinuation of U.S. application Ser. No. 12/639,734, filed Dec. 16,2009, now U.S. Pat. No. 8,425,554, which claims the benefit of U.S.Provisional Application No. 61/138,041, filed Dec. 16, 2008, thedisclosures of which are incorporated by reference in their entiretyherein.

FIELD OF THE INVENTION

The present invention relates to the field of surgery and, moreparticularly, to a suture passing K-wire used for small joint andligament reconstructions.

BACKGROUND OF THE INVENTION

“Hallux valgus” or “hallux abducto valgus” is associated with buniondeformity, where “hallux” refers to the great toe, “valgus” refers tothe abnormal slant of the great toe, and “abducto” refers to theabnormal slant or inward leaning of the great toe towards the secondtoe.

The abnormalities associated with bunion development are caused by abiomechanical abnormality, where certain tendons, ligaments, andsupportive structures of the first metatarsal are no longer functioningcorrectly. This biomechanical abnormality may be due to the structure ofthe foot - flat feet, excessive ligamentous flexibility, abnormal bonestructure—or certain neurological conditions.

The treatment of hallux valgus deformity includes an assessment of thehallux valgus angle, the intermetatarsal angle and the contribution ofan interphalageus deformity. Additionally, the presence or absence ofarthritic involvement of both the first metatarsocuneiform joint and thefirst metatarsophalangeal joint are also assessed.

The orientation of the distal metatarsal articular angle and theorientation of the first metatarsocuneiform joint are also considered.

Various methods to correct the intermetatarsal angle are known. Softtissue correction can be achieved by suturing the lateral capsule of thefirst metatarsal to the medial capsule of the second metatarsal,incorporating the intervening, previously released adductor tendon. Aloss of reduction can occur due to the forces that oppose the suturerepair as well as the possibility that poor tissue quality cancontribute to a loss of reduction.

When more rigid deformities of the intermetatarsal angle are present, itis generally reduced by using a distal or proximal osteotomy of thefirst metatarsal. Typically, a surgeon cuts into the foot near thebunion, and removes the excess growth of bone with a bone saw. Dependingon the degree of deformity, the surgeon may need to cut into the bone ofthe great toe and realign the bones so that the great toe no longerslants to the outside. Improving the angle of the great toe andrepairing the metatarsal bones may require a fastening means to holdthem in place. The incisions are later closed with stitches, and abandage is applied.

Such osteotomies can be technically challenging and difficult toperform. Further, the consequences and potential complications from suchsurgical procedures is a daunting list that includes delayed union,malunion, nonunion, excessive shortening of the first metatarsal,avascular necrosis, hardware failure and prolonged protected ambulation.

There is a need for a bunion repair technique that is simple, flexibleand is performed by a minimally invasive lateral approach, with indirectplacement of buttons across the first and second metatarsal. Also neededis a suture passing Kirschner wire (K-wire) that is configured to passsmall suture between one or two bones without “binding” the suture inthe bone tunnel.

SUMMARY OF THE INVENTION

The present invention overcomes the disadvantages of the prior art andfulfills the needs noted above by providing a surgical procedure forbunion repair using a suture passing K-wire configured to easily passthrough bone tunnels with suture trailing. The suture passing K-wireincludes a guide pin with a multi-diameter shaft (i.e., comprising atleast two regions or sections that have different diameters) and a loopwhich is securely attached to an end of the guide pin (preferably to thesmaller diameter section of the guide pin). The reconstruction systemmay be formed of a pair of buttons connected by a flexible strand. Theprocedure offers indirect placement of buttons and a minimally invasiveapproach. The multi-diameter shaft with the K-wire tip allows drillingdirectly into bone while small suture can be passed between one ormultiple bones without “binding” suture into bone tunnels. The procedurealso allows passage of the suture in the same step as drilling (forexample, passage of the suture when drilling lateral to medial, from thesecond metatarsal to the first metatarsal).

These and other features and advantages of the present invention willbecome apparent from the following description of the invention that isprovided in connection with the accompanying drawings and illustratedembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a side view of a suture passing K-wire of the presentinvention;

FIG. 2( a) illustrates a side view of the guide pin (the shaft) of thesuture passing K-wire of FIG. 1;

FIG. 2( b) illustrates a cross-sectional view of the guide pin (theshaft) of FIG. 2( a) taken along line C-C of FIG. 2( a);

FIG. 2( c) illustrates an enlarged view of the detail A (trocar tip) ofthe guide pin (the shaft) of FIG. 2( a);

FIG. 2( d) illustrates an enlarged view of the detail B of the guide pin(the shaft) of FIG. 2( a);

FIG. 2( e) illustrates an enlarged view of the detail D of the guide pin(the shaft) of FIG. 2( a);

FIG. 3( a) illustrates the suture loop of the suture passing K-wire ofFIG. 1, prior to assembling the suture loop to the guide pin;

FIG. 3( b) illustrates the suture loop of the suture passing K-wire ofFIG. 1, subsequent to assembling the suture loop to the guide pin; and

FIGS. 4-12 illustrate subsequent steps of an exemplary method of bunionrepair using the suture passing K-wire of FIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides methods and apparatus for bunion repair.The present invention utilizes a suture passing K-wire for passing aflexible strand attached to a reconstruction system (for example, asuture-button construct) that is placed across the first and secondmetatarsals. The suture passing K-wire of the present invention isconfigured to easily pass through bone tunnels with suture trailing.

The suture passing K-wire includes a guide pin with a multi-diametershaft (i.e., comprising at least two regions or sections that havedifferent diameters) and a loop (for example, a nitinol loop) which issecurely attached to an end of the guide pin (preferably to the smallerdiameter section of the guide pin). The reconstruction system may beformed of a pair of buttons connected by a flexible strand. Theprocedure offers indirect placement of buttons and a minimally invasiveapproach.

The suture passing K-wire is also provided with a sharp tip (trocar tip)so that the K-wire can drill directly into bone while small suture ispassed between one or multiple bones without “binding” suture into bonetunnels. The procedure also allows passage of the suture in the samestep as drilling (for example, passage of the suture when drillinglateral to medial, from the second metatarsal to the first metatarsal).

According to an exemplary embodiment, the suture passing K-wire of thepresent invention has a decreased diameter along the shaft of the wire,to ease passage of the suture through small bone tunnels. Once thethicker region of the suture passing K- wire has exited the bones, thesmaller diameter section can easily pass through both bone tunnels withsuture trailing.

The suture passing K-wire may be employed with a reconstruction systemsuch as a suture-button construct formed of a pair of buttons connectedby at least one flexible strand (for example, at least one suturestrand). The buttons may have various shapes and configurations, and maybe provided with various apertures (in different numbers and withdifferent configurations), to allow the passage of the at least oneflexible strand. For example, the reconstruction system may include afirst button which may be round and which may include a first set ofapertures, and a second button which may be oblong and which may includea second set of apertures (which may be similar to, or different from,the first set of apertures). The buttons may be formed, for example, oftitanium, stainless steel, PolyEtherEther-Ketone (PEEK) or Poly-L LacticAcid (PLLA). If the flexible strand is suture, the suture strand may beFiberWire® suture strand, sold by Arthrex, Inc. of Naples, Fla. Detailsof reconstructions systems (suture button constructs) which may beemployed in the methods of the present invention are set forth in U.S.Pat. No. 7,875,058, the disclosure of which is incorporated in itsentirety herewith.

Referring now to the drawings where like elements are designated by likereference numerals, FIGS. 1-3 illustrate a suture passing K-wire 100formed according to an exemplary embodiment of the present invention.FIGS. 4-12 illustrate a surgical method for repairing bunions using thesuture passing K-wire 100 of FIGS. 1-3.

As illustrated in FIGS. 1-3, suture passing K-wire 100 includes a guidepin 10 having a multi-diameter shaft, i.e., a shaft comprising at leasttwo regions or sections that have different diameters. For example,first or distal region 10 a has a first diameter (of about 1.1 mm) thatis greater than a second diameter of second or proximal region 10 b (ofabout 0.75 mm). Connecting region 11 (shown in more detail in FIG. 2(d)) couples the first and second regions 10 a, 10 b. In an exemplaryembodiment only, connecting region 11 has a tapered diameter (i.e.,gradually decreasing from the first diameter of distal region 10 a tothe second diameter of the proximal region 10 b).

Preferably, the guide pin of K-wire 100 is formed of stainless steel orother metals or alloys known in the art. The first or distal region 10 aterminates in a sharp tip (trocar tip) 15 which may also be formed ofstainless steel. In an exemplary embodiment, the length L of the guidepin 10 is about 180-200 mm, more preferably of about 190 mm, with firstregion 10 a having a length La (FIG. 2( b)) of about 110 mm and secondregion 10 b having a length Lb (FIG. 2( b)) of about 80 mm.

A loop 20 (for example, a Nitinol loop 20) is securely attached to anend of the guide pin 10. FIG. 1 shows loop 20 attached to the smallerdiameter section 10 b of the guide pin 10, securely fitted within cutoutsection 22 of the shaft or guide pin 10 (as shown in detail in FIG. 2(e), for example). Loop 20 may be attached to cutout section 22 of theproximal shaft region 10 b by various methods known in the art such ascrimping, for example. FIGS. 3( a) and 3(b) illustrate the loop 20before and after assembling to the cutout section 22. Preferably, thediameter of the wire 20 is of about 0.25 mm, so that when the ends 24 ofthe wire are brought together to form the loop, the combined end region25 has a diameter about equal to the diameter of the cutout section 22of the guide pin (i.e., of about 0.5 mm) to allow secure engagement ofthe loop to the guide pin.

By providing the suture passing K-wire 100 of the present invention witha decreased diameter along the shaft of the wire, the passage of thesuture through small bone tunnels is eased. In this manner, once thethicker region 10 a of the suture passing K-wire 100 has exited thebones, the smaller diameter section 10 b can easily pass through one orboth bone tunnels with suture trailing.

FIGS. 4-12 illustrate an exemplary surgical method for repairing bunionsusing the suture passing K-wire 100 of FIGS. 1-3 employed in conjunctionwith a reconstruction system 200 that includes a pair of buttonsconnected by a flexible strand (an exemplary Mini TightRope®, sold byArthrex, Inc.). Suture passing K-wire 100 of the present invention maybe employed, however, with any reconstruction system including, forexample, a button with a flexible strand attached therein, or any numberof buttons with corresponding flexible strands, or with a sutureanchor-button construct (that comprises a fully threaded suture anchorconnected by suture extending therefrom to a round button, which ispreferably a cup-shaped button). Suture passing K-wire 100 of thepresent invention may be employed not only for bunion repairs (asdetailed below and used in conjunction with a special suture-buttonconstruct) but also for passing a flexible strand (such as suture) or aplurality of flexible strands through any bone tunnels or bone openings(or through tunnels formed in adjacent bones or bone segments).

As shown in FIG. 4 (for the distal approach), the first interspacerelease is first preformed through an incision 50 made between thedistal first and second metatarsals. A dorsal medial or medial incisioncan also be used with appropriate distraction of soft tissues.

To realign the fibular sesamoid, the adductor tendon is detached fromboth the base of the proximal phalanx and the fibular sesamoid (FIG. 5).The deep intermetatarsal ligament and lateral capsule are released. Anysesamoid adhesions to the intermetatarsal ligament are also released.The reduction of the IM angle following complete soft tissue release ismanually tested.

FIG. 6 shows the incision of the medial capsule, exposing the entiremedial eminence. The medial eminence is removed, preserving the sesamoidgroove on the plantar aspect of the 1st metatarsal.

Reference is now made to FIG. 7. The lateral second metatarsal isexposed at site 51 for placement of a reconstruction system (forexample, a suture button construct 150 such as the Mini TightRope® 150,as shown in FIG. 9( a)). As noted above, details of suture buttonconstructs which may be employed in the methods of the present inventionare set forth in U.S. Pat. No. 7,875,058. As detailed in U.S. Pat. No.7,875,058, suture button construct 150 may comprise first and secondbuttons with first and second pluralities of apertures that facilitateengagement of a flexible strand (for example, a suture strand) threadedtherein. In an exemplary embodiment, the first button has a roundconfiguration (with four circular apertures) and the second button hasan oblong configuration (with two triangular apertures). The buttons mayalso have similar configurations, depending on the characteristics ofthe anatomical site and structures undergoing repair. For simplicity,the buttons of the suture button construct 150 (the Mini TightRope® 150)of the present invention will be referred to as buttons 155; however, itmust be understood that these buttons may have different configurationsand geometries. The flexible strand may be formed of suture, for examplea high strength suture material such as FiberWire® suture, sold byArthrex, Inc. of Naples, Fla., and described in U.S. Pat. No. 6,716,234,the disclosure of which is incorporated by reference herein. TheFiberWire® suture is formed of an advanced, high-strength fibermaterial, namely ultrahigh molecular weight polyethylene (UHMWPE), soldunder the tradenames Spectra® (Honeywell) and Dyneema® (DSM), braidedwith at least one other fiber, natural or synthetic, to form lengths ofsuture material. The suture may optionally include filaments of variouscolors.

Referring back to FIG. 7, the first metatarsal is reduced withprovisional fixation to the second metatarsal. A C-arm is used to assureproper placement of a 1.1 mm tapered suture passing K-wire 100 a of thepresent invention, at the center of the second metatarsal shaft, about2-3 mm proximal to the neck of the second metatarsal. The secondmetatarsal is elevated and exposed with an elevator and a small rakeretractor (soft tissue) prior to K-wire insertion. The K-wires 100 a,100 b (FIG. 7) are placed from the second metatarsal through the firstmetatarsal and inserted (drilled into the bone) with the thicker region10 a first, followed by the trailing, narrower diameter region 10 b withattached loops 20. The wires 100 a, 100 b exit just proximal to theexcised medial eminence, approximately 5 mm apart. Preferably, thesuture passing K-wires 100 a, 100 b are placed simultaneously.

Reference is now made to FIG. 8. With the first metatarsal manuallyreduced, the K-wires 100 a, 100 b are positioned so that the taperedportions just exit the medial cortex of the first metatarsal. This willallow easy passage of the #2 FiberWire® through the drilled holes.

FIG. 9 illustrates the distal construct 150 consisting of an exemplaryflexible strand 151 threaded through a button 155 (for example, a #2FiberWire® strand 151 with two free #2 FiberWire® ends threaded throughan oblong button 155, as shown in FIG. 9( a)). One free end of the #2FiberWire® 151 is inserted through each of the exposed Nitinol wireloops 20 on the lateral side of the second metatarsal. The suturepassing K-wires 100 a, 100 b are pulled medially, passing the free endsthrough the 1.1 mm pilot holes, as shown in FIG. 9( b).

The technique described above positions the suture knots on the medialfirst metatarsal. Alternatively, the knots may be also placed lateral tothe second metatarsal, as shown in FIGS. 9( c)-(e) and with reference tothe following steps: One limb of suture 151 is passed through the distalhole 20 using the suture passing K-wire 100 a (FIG. 9( c)). The free endof #2 suture 151 is threaded through both holes of the button 155 (FIG.9( d)). Using a second suture passing K-wire 100 b, an accessory strandof 2-0 FiberWire® (formed as a loop) is pulled through the proximal hole(FIG. 9( d)). The 2-0 FiberWire® loop acts as a suture shuttle, pullingthe #2 suture from medial to lateral. As shown in FIG. 9( e), thenitinol loop portion of the passing wire is cut. The #2 FiberWire®strand (about 1″) is passed through the 2-0 FiberWire® loop and pulledlaterally. The construct can now be completed with a button and threeknots lateral to the second metatarsal.

Reference is now made to FIG. 10. After the suture has been passed fromlateral to medial, one end of the #2 FiberWire® is rethreaded throughopposite holes in the oblong button. If round buttons are used, thebuttons are threaded in the same way using opposite holes (see FIG. 11).The first of the two reconstruction systems 150 (the two Mini TightRope®constructs 150) is tied down with one knot, while the second construct150 is placed about 5-7 mm proximal from the first construct 150. Thedrilling instructions are repeated (as described above) to place thesecond construct 150. The surgeon should check the IM angular correctionon C-arm prior to final tightening, using three knots for closure.

A final, double construct 400 completed using a disposables kit withfour round buttons is shown in FIG. 11. FIG. 12 illustrates another viewof a final, double construct 400 formed according to a method of thepresent invention.

A disposable kit 300 of the present invention may comprise, for example,four buttons (for example, four round buttons or four oblong buttons, ortwo round and two oblong buttons), FiberWire® suture, four 1.1 mm suturepassing K-wires and suture passing K-wire (about 8″ long). The kit mayalso comprise a skin marking pen and ruler, and may be employed inconjunction with various accessories (such as, for example, 2.0FiberWire® (about 38 inches) and FiberWire® scissors, among others.

Hallux Valgus Post-op Protocol

-   Surgery & Post-op Day 1-4-   Posterior fiberglass splint-   Heel weight-bearing only-   Post-op Day 4- 28 (4 weeks)-   Heel weight-bearing only-   Pneumatic walking boot/Cam walker-   Darco bunion splint to maintain position of great toe-   Post-op Day 28 (4 weeks-6 weeks)-   Possible start in athletic shoe; only lateral or heel weight-bearing-   Post-op Day 42 (6 weeks)-   Weight-bear through great toe

Recovery depends on soft tissues scarring to hold correction and unloadthe device. If premature weight-bearing through medial forefoot isinitiated, the second metatarsal responds similarly to a stress fracturewith long-term edema and mild pain.

The surgical method can also optionally be performed in the oppositedirection as that described above, such that the first button ends up onthe lateral side of the second metatarsal.

In yet another embodiment of the present invention, the suture passingK-wire of the present invention may be used with a suture anchor-buttonconstruct for bunion repair. In an exemplary embodiment only, the sutureanchor-button construct comprises a fully threaded suture anchorconnected by suture extending therefrom to a round button, which ispreferably a cup-shaped button. The suture anchor is inserted through apreformed hole formed in the first metatarsal and into a smallerdiameter preformed hole in the second metatarsal, which it is screwedinto place. After the first metatarsal and the second metatarsal arepushed together to correct the intermetatarsal angular deformity, thebutton is advanced upon against the medial surface of the firstmetatarsal, with the cup of the button in the hole, and secured in placeby the tying the suture strands passing through the button.

Although suture passing K-wire 100 of the present invention has beendetailed above in conjunction with bunion repairs (and in conjunctionwith a special suture-button construct), the invention is not limited tothis exemplary embodiment. Thus, suture passing K-wire 100 of thepresent invention may be employed for passing a flexible strand (such assuture) or a plurality of flexible strands through any bone tunnels orbone openings (or through tunnels formed in adjacent bones or bonesegments).

While the present invention is described herein with reference toillustrative embodiments for particular applications, it should beunderstood that the invention is not limited thereto. Those havingordinary skill in the art and access to the teachings provided hereinwill recognize additional modifications, applications, embodiments andsubstitution of equivalents all fall within the scope of the invention.Accordingly, the invention is not to be considered as limited by theforegoing description.

1. A method of bone repair of a small joint, comprising: providing asuture passing K-wire in the vicinity of a first bone and of a secondbone of a small joint, the suture passing K-wire comprising a taperedguide pin having a first region with a first diameter and terminating ina sharp tip, and a second region with a second diameter and terminatingin an eyelet, the second diameter being smaller than the first diameter;passing a flexible strand through the eyelet of the K-wire; insertingthe K-wire into the first bone and advancing the K-wire from the firstbone to the second bone; and passing the flexible strand through thefirst and second bones.
 2. The method of claim 1, wherein the step ofadvancing the K-wire into the first and second bones is conductedsimultaneously with the step of passing the flexible strand through thefirst and second bones.
 3. A method of bone repair, comprising:inserting a suture passing K-wire from a second bone of a small joint toa first bone of the small joint, the suture passing K-wire comprising atapered guide pin having a first region with a first diameter andterminating in a sharp tip, and a second region with a second diameterand terminating in an eyelet, the second diameter being smaller than thefirst diameter, the K-wire being inserted so that the distal end of thesecond region is adjacent a cortex of the first bone and the eyelet isadjacent a cortex of the second bone; passing a flexible strand of asuture-button construct through the eyelet of the K-wire; and pullingthe K-wire with the flexible strand from the second bone to the firstbone so that the K-wire exits the first bone, the flexible strandextends between the first bone and the second bone, and the button isengaged against the second bone.